MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 APOLLO; AGENT, INJECTABLE, EMBOLIC

Model Number	105-5095-000
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that an apollo catheter was observed to have a leak at the distal location during use.The patient was undergoing surgery for treatment of an arteriovenous malformation (avm).It was noted the patient's vessel tortuosity was moderate.While embolizing the avm with onyx, the physician noticed onyx exiting the catheter about 10cm from the tip.The catheter was removed.No patient symptoms or complications were associated with this event.Right internal carotid artery (ica) access vessel diameter was 2 mm.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).
Additional Manufacturer Narrative
H3: analysis results were not available at the time of this report.A follow-up will be sent once analysis is complete.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Update b5.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received.Lesion characteristics were unknown.The model and lot number of the onyx liquid embolic agent were also unknown.The procedure was completed successfully.Upon injection of the liquid embolic agent into the apollo catheter, no resistance was encountered.The physician performed a continuous injection, and the injection rate was followed as indicated in the ifu.The liquid embolic agent did not become embedded in an unintended location, and no medical intervention was required as a result of the event.No images of the ruptured catheter were available.The anatomical location of the apollo tip was unknown, and the subject was recovering well from the procedure.

• Brand Name: APOLLO
• Common Device Name: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 24777990
• Report Number: 2029214-2026-00600
• Device Sequence Number: 14968754
• Product Code: MFE
• UDI-Device Identifier: 00763000446741
• UDI-Public: (01)00763000446741(17)280909(10)D070851
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 105-5095-000
• Device Catalogue Number: 105-5095-000
• Device Lot Number: D070851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/13/2026; 05/07/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/23/2026; 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown